Pfizer Limited
Overview
Pfizer Limited is a leading pharmaceutical company in India, which operates as a subsidiary of Pfizer Inc., a global pharmaceutical giant. The company focuses on developing and manufacturing a broad portfolio of medicines and vaccines for various therapeutic areas.
Therapeutic areas
API / Drug Master Files
Pfizer Limited holds 4 active (72 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- ACTIVATED CALICHEAMICIN DERIVATIVEActive2015-12-11
- PRASTERONE ACETATEActive2014-12-11
- ALPHAMETHYL EPOXIDEActive1996-09-11
- HEPARIN SODIUM USPActive1976-08-03
- CABERGOLINE USPInactive2014-12-12
- LIPITOR (ATORVASTATIN CALCIUM) 10MG, 20MG, 40MG, 80MG ORALTABLETSInactive2009-01-29
- FLUMETHASONEInactive2001-08-01
- TROLEANDOMYCINInactive1998-09-01
- CEFOPERAZONE SODIUMInactive1998-09-01
- PENICILLIN G SODIUMInactive1998-09-01
- AMPHOTERICIN BInactive1998-09-01
- TETRACYCLINE HYDROCHLORIDEInactive1998-09-01
- ERYTHROMYCINInactive1998-09-01
- ERYTHROMYCIN STEARATEInactive1998-09-01
- AMPICILLIN TRIHYDRATEInactive1998-09-01
Showing 15 of 72 Drug Master Files.
FDA compliance signals
50 FDA enforcement records linked to this company.
- recall — Class II2025-08-27
Lack of Assurance of Sterility.
- recall — Class II2025-08-27
Lack of Assurance of Sterility.
- recall — Class II2025-08-20
Subpotent drug
- recall — Class II2025-08-06
CGMP Deviations; particulates identified during visual inspection
- recall — Class II2025-08-06
CGMP Deviations; particulates identified during visual inspection
- recall — Class II2025-07-02
Discoloration; discolored solution from cracked vials
- recall — Class II2024-07-03
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
- recall — Class II2024-07-03
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
- recall — Class I2024-01-31
Presence of particulate matter: glass
- recall — Class I2024-01-24
Presence of Particulate Matter; identified as glass
- recall — Class I2024-01-24
Presence of Particulate Matter; identified as glass
- recall — Class I2024-01-24
Presence of Particulate Matter; identified as glass
- recall — Class I2023-11-15
Presence of Particulate Matter: identified as glass.
- recall — Class I2023-11-15
Presence of Particulate Matter: identified as glass.
- recall — Class I2023-11-15
Presence of Particulate Matter: identified as glass.
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